National Consumers League response to the Request for Information regarding FDA regulation of CBD

August 25, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – On August 17, the National Consumers League responded to the Request for Information regarding FDA-Regulation of CBD.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address the need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research. Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD. In response, NCL expanded our educational campaign and established Cannabis Consumer Watch.” 

The full letter can be found here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

Safety in question: The alarming disparities between cannabis product health claims and research, and the magnified risks for women

By Health Policy Intern Grace Lassila

July 27, 2023

When I started my National Consumers League (NCL) internship in May 2023, I quickly dove into NCL’s health policy work. NCL is leading on several efforts to protect consumers –one area of focus that stood out to me is their work in the cannabis policy space. NCL is a founding member of Cannabis Consumer Watch (CCW), which educates consumers on cannabinoids, their effects, the risks related to the unregulated marketplace, and the ways policymakers and regulators can help protect consumers. NCL is also a part of the Collaborative for Cannabinoid Science and Safety (CCSS), which also works to educate people about cannabinoids and policy in the interest of public health.

CCW’s “test your cannabis knowledge” quiz was shocking for me. Going into the quiz, I was fairly confident about my knowledge, but as I started getting wrong answer after wrong answer, I realized I had no idea that not only are these products under-researched, but they may pose serious public health risks for consumers. Products can be sold, without having gained FDA approval, making false claims about their medicinal abilities.  And side effects are not adequately researched or revealed to consumers.

One particularly concerning aspect of the cannabis marketplace is that while CBD or Delta-8 or other cannabis products are often marketed to women, there is a concerning lack of research into the safety of these products for women. Historically, misogyny and sex discrimination have made women’s health severely under-researched and underfunded. More research on diseases, disorders, and medication is conducted on men, not women. Women are misdiagnosed far greater than men are, and experience dangerous health outcomes because of it (Greenhalgh). And without sufficient research and data on women’s health, it is incredibly difficult for legislators to write policy (Adams). Overall, for women’s health to improve, more resources need to be devoted to this issue.

Despite cannabis companies’ marketing efforts that claim their products can help with anything from menstrual cycle-related pain to morning sickness, there is little insight into the effects of cannabis or cannabis derivatives on women, pregnant people, nursing parents, and newborns. What we do know is that the risks are very real – a recent study found that THC use during pregnancy was linked to changes in fetal development and several studies have shown that CBD can be transferred to a baby via breast milk. The FDA strongly advises against THC or CBD usage while pregnant or breastfeeding. And, given the evidence currently available, I would caution any women from using these products for medical benefit.

The lack of regulation, as well as research, is very concerning. Because the FDA currently does not regulate these products, consumers have no way of knowing whether the dosage, ingredients, or claims on the label are accurate and no way of knowing whether or not they are contaminated. Though some products may acknowledge they are ‘Not Approved by FDA,’ many consumers may not see this fine print – and assume that anything they can buy at their local grocery store must be safe for consumption. While the risks of an unregulated cannabis marketplace affects all consumers, women who need medical health and relief and turn to cannabis products may be more at risk.

The good news is that in January of this year, the FDA recognized this grey area for regulation – particularly for CBD – and stated that CBD would not be regulated as a food and dietary supplement anymore, because of the unknown safety risks, and requesting that Congress act quickly to protect public health and the consumers involved.

While cannabis products are often marketed as a miracle drug, they are not. While there may be some health benefits, without comprehensive research and regulation of these products, the risks outweigh the potential good. Consumers remain responsible for making their health decisions, and women in particular should be vigilant. The FDA is heading in the right direction but more must be done to protect consumers – and women in particular. I encourage you to learn more about a safe path forward here and help NCL raise awareness of this important issue.

Sources:

Adams, Katie. “Women’s Health Is Suffering Due to Lack of Research and Funding, Experts Say.” MedCity News, 9 Dec. 2022, medcitynews.com/2022/12/womens-health-is-suffering-due-to-lack-of-research-and-funding-experts-say/#:~:text=Women’s%20health%20has%20been%20historically,healthcare%20conference%20in%20Washington%2C%20D.C.

Eversheds Sutherland. “FDA Says ‘No’ to CBD: Now What?” FDA Says “No” to CBD: Now What? – Eversheds Sutherland, us.eversheds-sutherland.com/mobile/NewsCommentary/Legal-Alerts/256713/FDA-says-no-to-CBD-Now-what#:~:text=Since%202018%2C%20the%20FDA%20has,%2Dapproved%20drug%20(Epidiolex). Accessed 6 July 2023.

Greenhalgh, Ally. “Medicine and Misogyny: The Misdiagnosis of Women.” Confluence, 5 Dec. 2022, confluence.gallatin.nyu.edu/sections/research/medicine-and-misogyny-the-misdiagnosis-of-women.

Grinspoon, Peter. “Cannabidiol (CBD): What We Know and What We Don’t.” Harvard Health, 24 Sept. 2021, www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476.

“What You Should Know about Using CBD When Pregnant or Breastfeeding.” U.S. Food and Drug Administration, www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding#:~:text=FDA%20strongly%20advises%20against%20the,during%20pregnancy%20or%20while%20breastfeeding.&text=Cannabis%20and%20Cannabis-derived%20products,products%20appearing%20all%20the%20time. Accessed 6 July 2023.

New research reiterates the need for consumer caution, federal protection related to marijuana companies misleading claims

March 13, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – Data Science Solutions, LLC, in partnership with NCL, today released new research that dives into false or misleading medical claims made by several leading marijuana companies on their social media platforms. The analysis qualitatively observes how these claims are framed to appeal to consumers, determines the reach of their messaging, and identifies policy solutions to help increase state and federal regulatory and enforcement action to end false – potentially harmful – marketing.

“Consumers should understand what they’re up against when perusing social media,” said Sally Greenberg, Executive Director of the National Consumers League. “Twitter in particular may be viewed as a more trustworthy platform and licensed marijuana companies will often site reliable academic institutions or studies in a misleading way. These companies use Twitter to target consumers and declare that their products can help address, even treat, health issues from ‘pain’ to neurological diseases, even cancer. However, these claims are not backed by sound, clinical research – though the data is lacking at best, companies don’t let that stop them from trying to profit.”

The FDA, FTC, and Congress can do more to protect consumers and hold these companies accountable. The paper urges Congress to “encourage FDA and FTC to expand their enforcement against therapeutic claims made by cannabis companies and provide the necessary resources for the FDA to conduct effective oversight of marijuana-related health claims on social media platforms,” And recommends FDA begin using automated tools to monitor cannabis companies’ social media posts efficiently and effectively.

“Consumers deserve better,” said Greenberg. “These companies can and should market their products in an honest way and put consumer health over profits. Investing in thorough research so that we may better understand the true therapeutic potential of marijuana would be a win-win for all.”

To learn more about the risks of unregulated cannabis products, visit cannabiswatch.org.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

NCL statement on FDA decision regarding CBD regulatory framework

January 27, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, applauds the FDA’s decision that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

NCL has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded.

“This announcement is a critical step in the right direction. NCL supports FDA’s assessment that the existing dietary supplement and conventional food pathways are not appropriate for CBD,” said NCL Executive Director Sally Greenberg. “We are encouraged to see regulators prioritizing science and consumer safety, and we are committed to working with Congress, the FDA and other stakeholders to explore potential regulatory pathways that prioritize management of health risks associated with CBD and acceleration of rigorous research into cannabinoids’ therapeutic potential.”

“To that end, NCL was pleased to see FDA highlight the need for risk management tools, including clear labels, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”

Along with our partners – the Consumer Federation of America and the Community Anti-Drug Coalitions of America – NCL created the Consumers for Safe CBD in 2019, now Cannabis Consumer Watch, to educate consumers about the potential dangers of CBD in an unregulated market.

“We will continue advocating for policies that preserve meaningful, scientific research incentives while protecting public health,” Greenberg said. “As Congress works to develop a new regulatory pathway for CBD, it is critical that we bear in mind there’s greater urgency to address the risks posed by intoxicating cannabinoid products in the hemp market. As we’ve seen, these products pose significant risks to consumers, and must be addressed. Science should continue to guide policy discussions to ensure a safe and effective regulatory pathway.”

To learn more, visit cannabiswatch.org.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NCL welcomes FDA heightened concerns related to CBD products

December 29, 2022 [Updated]

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, is welcoming of the FDA’s heightened concern and attention to consumer safety risks in the CBD or cannabidiol consumer product market.

“The FDA’s continued engagement and work in the CBD consumer product market is critical to protecting consumer safety – the agency’s increased attention to CBD products is welcome news,” said Sally Greenberg, NCL’s Chief Executive Officer.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address this need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research.

Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD, which is why NCL is now shifting its focus to cannabis more broadly with the establishment of Cannabis Consumer Watch. Cannabidiol (CBD) is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

“NCL called on the FDA to develop regulations for the CBD marketplace. We also asked the CBD industry to ensure safety and promote a pathway for new products through clinically tested scientific research,” said Greenberg.

The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the CBD marketplace.

“Since 2019, NCL and other groups like the Consumer Federation of America and Community Anti-Drug Coalitions of America have been asking the FDA to step in and address the CBD marketplace – which is currently a ‘Wild West,’ with myriad unsubstantiated claims made by many in the industry about the so-called benefits of CBD products for everything from sleep disorders to cancer to pain relief, without regard to safe dosages,” Greenberg noted. “We want the agency to establish a regulatory framework for the legal sale of appropriate cannabis and cannabis-derived products. Some industry members have been asking for rules of the road as well. Any regulatory framework FDA recommends for cannabis-derived products must prioritize consumer safety and address the safety risks the agency has identified.”

There is only one FDA-approved drug on the market that employs CBD as its active ingredient – Epidiolex – a medication to treat a rare form of childhood epilepsy. That drug has undergone the rigorous FDA approval process and thus has substantiated therapeutic benefits that outweigh the risks which can be managed by prescribing physicians.

Cannabis Consumer Watch will continue to work to educate consumers about the potential dangers of CBD in an unregulated market and encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NEW RESEARCH: CBD companies exploiting academic partnerships for marketing purposes

January 20, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The Journal of Studies on Alcohol and Drugs today released new research that reveals the various tactics cannabidiol (CBD) companies use to thwart the Food and Drug Administration (FDA) review process and assert that their therapeutical claims are backed by science.

The study, The Use of Academic Research in Medical-Cannabis Marketing: A Qualitative and Quantitative Review, illuminates the need for FDA regulatory approval and stronger oversight to address the risks to consumers and patients alike when companies exploit that system. The findings reveal nearly 1,000 health claims touting CBD’s ability to mitigate symptoms or treat mental health, autism, pain, sexual health, AIDS, cancer, COVID-19, and more, providing just a snapshot of the current, unregulated marketing tactics being used to mislead the public.

The research was commissioned by Consumers for Safe CBD, a campaign spearheaded by the National Consumers League and conducted by Data Science Solutions. The research took place in the summer of 2020 and was published today in the Journal.

“It’s important that consumers understand what they’re up against when it comes to the current marketplace,” said Sally Greenberg, Executive Director of the National Consumers League. “Day in and day out we see CBD products promoted by celebrities and ‘health experts’ who have no clue what is truly in the products they push. This research helps give a snapshot of just how many misleading claims are out there and will help consumers better understand how to identify — and know to question — marketing red flags.”

“Unfortunately, many CBD manufacturers talk quite a bit about research, but have rarely engaged in the kind of large-scale randomized controlled trials necessary to establish that a drug is safe and effective,” said Theo Caputi, M.P.H, M.SC. author of the study. “CBD products are flooding the retail marketplace — readily available to consumers — and this review shows a serious need for adequate research and testing to ensure safety of these products and effectiveness for the claims companies are making.”

Most of the top medical marijuana companies analyzed:

  • use the existence of academic partnerships and observational relationships in an effort to legitimize health claims, despite having little to no clinical trial activity;
  • routinely use academic research in marketing strategies (“research as marketing”) to mislead the public; and,
  • evade FDA approval process by creating their own pseudo-approval process, making products appear legitimate, safe, effective, and eligible for insurance coverage for a range of health claims through these “research as marketing” tactics.

“It is alarming to see so many companies purposefully evading the FDA process — the gold standard in consumer protection — and making therapeutic claims with little to no real, clinical evidence,” said Greenberg. “Many of these companies have received warning letters from the FDA, yet these harmful and misleading tactics continue. It’s time for Congress to empower FDA to use its full authority to protect consumers. Consumers for Safe CBD will continue to serve as a watchdog to ensure CBD products are safe and effective.”

The CBD market continues to grow despite the FDA stating that CBD cannot be generally regarded as safe (GRAS) for use in food and beverage products. According to a Statista report, CBD sales in the U.S. reached $4.6 billion in 2020. By 2026, the market is expected to grow to $16 billion. Consumers, through these “research as marketing” tactics, have been led to believe that CBD has both medical benefits and health maintenance effects. However, there is only thorough, scientific-backed proof of medical benefits in the one and only FDA-approved CBD prescription drug product available.

“It is arguably unethical and certainly misleading for commercial entities to use the legitimacy of early scientific research — and the announcement of such endeavors — as a marketing tool,” Caputi added, “In fact, this ‘research’ used — or even simply announced in press releases — is not nearly substantial enough to ensure safety and effectiveness of these products for therapeutic use. We must rely on the rigorous FDA approval process to be sure these products meet the gold standard for safety and efficacy.”

Click HERE to read the full study in the Journal of Studies on Alcohol and Drugs.

To  learn more about the risks of unregulated CBD, visit 4safecbd.org.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

What’s in that gummy bear could be hazardous to your kid’s health

CBD-infused foods and candies are often packaged and marketed to appeal to children, but buyer beware – there are a number of harmful ingredients that could be in a seemingly harmless gummy bear. Parents, teachers, guardians, and loved ones should know that none of the non-prescription CBD products on the market today – and the false medical claims often used to market these to consumers – have been tested or approved by the FDA.

NCL concerned as Senate bill puts consumers at risk from unregulated CBD

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—On May 19, Senators introduced the Hemp Access and Consumer Safety Act (S. 1698) which directs the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary ingredients or supplements. The National Consumers League (NCL) has long been concerned about the risks posed to consumers by unapproved cannabis-derived products. There is little research on the health and safety of CBD products, and as such the NCL does not support any legislation that would bypass the FDA’s regulatory authority and rigorous scientific review.

Currently, manufacturers and distributors of products containing CBD can petition the FDA for review and approval of a new ingredient as a dietary supplement (21 U.S.C. 350b). This approval process requires manufacturers and distributors to submit scientific data showing that the product is generally regarded as safe (GRAS). “Not only is there insufficient data to designate CBD products as GRAS, the FDA needs further data to determine safe dosage and concentration levels in order to set manufacturing and labeling requirements that ensure consumer safety,” said Jeanette Contreras, NCL Director of Health Policy.

As demonstrated in a white paper published by NCL, companies selling CBD products often focus their research efforts on weak and inexpensive studies, and then use the results for marketing purposes. “Current studies have not enhanced our scientific understanding of CBD, and policymakers should focus on incentivizing further clinical studies to bring new proven medical treatments to patients,” said Contreras. By mandating the FDA to regulate CBD as a dietary ingredient, S. 1698 would only further incentivize CBD manufacturers to forego rigorous clinical trials and the development of FDA-approved medicines. Easier approval as a dietary supplement will disincentivize real scientific research into any potential health benefits or risks of CBD products.

Under S. 1698, CBD manufacturers that make unwarranted claims of treating medical issues will seek expedited approval for their products as dietary supplements, rather than as drugs. We should be encouraging the development of new cannabis-derived medicines that have gone through the rigorous processes of randomized controlled trials and FDA approval. Considering the lack of existing research on CBD, this bill classifying CBD products as dietary supplements would irresponsibly lead to increased consumption of these products and limit the future development of cannabis-derived FDA approved treatments—while putting consumers at risk.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Consumer groups back FDA on NDI draft guidance

For immediate release: February 3, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—While the Biden Administration reviews late-hour regulations enacted by the Trump Administration, one important FDA guidance related to CBD deserves further consideration. The U.S. Food and Drug Administration recently withdrew its pending CBD guidance, which the agency had submitted last summer. These highly anticipated guidelines were meant to elaborate on FDA’s CBD enforcement policy as unregulated, untested CBD products continue to infiltrate the consumer market. The FDA has not yet shared a timeline for re-submitting the CBD guidance.

NCL launched Consumers for Safe CBD in 2019 to encourage the FDA to use its existing authority to curtail the proliferation of potentially dangerous, unapproved CBD products and to incentivize CBD research, clinical trials, and the creation of science-based CBD medicines.

NCL Executive Director Sally Greenberg released the following statement in response to the FDA pulling its guidance:

The early weeks of 2021 have brought about many changes – with a new Administration, a new Congress, and continued progress in the fight against COVID-19,  there is hope for a safer, healthier future. NCL will continue to do its part to protect consumers and promote public health.

Unfortunately, CBD manufacturers continue to make unsubstantiated medical claims about their products, putting consumers at risk. We remain hopeful that the FDA and the Biden Administration will join us in our efforts to protect consumers from the potential dangers that exist in the current unregulated, wild west CBD marketplace.

NCL urges the FDA to re-circulate an updated proposal that encourages further research into CBD and the development of science-based CBD medicines and uses the FDA’s authority to regulate the CBD marketplace to protect consumers from CBD products that may put them at risk. Consumers deserve a safer, healthier future. We simply cannot abandon this work now.

To learn more about NCL’s Consumers for Safe CBD campaign, click here. To learn more about FDA’s recent efforts related to CBD, click here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.